Project QA for Tech Transfer - Drug Substance Manufacture

Are you an experienced senior QA specialist with interest in Tech Transfer projects, quality and cross-organizational work?

Then you could be our new Project QA for Tech Transfer colleague!

Your New Role

Our work with many different biopharma companies means that Tech Transfers of Drug Substance processes are a key element in our current operation and future development.

You will take on a role as Project QA for Tech Transfer programs with involvement from early introduction throughout the engineering, clinical and PPQ phases of the transfer.

You will make sure that the quality aspects of the tech transfer project are in focus, prioritized and in compliance with the internal procedures, guidelines and quality agreements.

You will be part of the project core team and participate in project and customer meetings representing QA and ensuring consistent QA decisions.

You will work across the organization and liaison with the operational QA DS teams, DS manufacturing Support, Process Science, QC on quality related aspects. You will work closely with the Qualified Persons to ensure the strategy for release (DS confirmation) of clinical and PPQ batches.

You will maintain the oversight from the QA perspective of the project and be able to provide status to the Quality Management.

Main Responsibilities

• Support to Tech Transfer Projects from a quality aspect
• Participation in the Tech Transfer Project Core Group
• Review and approval of protocols and reports related to the Tech Transfer Project e.g. PPQ and PPQ Master Plans
• Review and approval of tech transfer documents such as supportive documents, risk evaluations, process control documents,
• QA lead on major deviations throughout the Tech Transfer Project supported by QA operations
• QA responsibility for the Tech Transfer change control record
• Participation in evaluation of customer requests and customer meetings

Your Skills & Talent

• A university degree within Pharmacy Physical, Chemical or Biological Science, Engineering or equivalent
• At least five years of experience with drug substance manufacturing in a compliance function/QA function
• Previous experience with tech transfer of bio-pharmaceutical products or processes
• CMO experience is preferable
• Fluency in English
• Experienced in interpretating legislation and guidelines

We hope you are

a proactive team player with a can-do attitude and excellent stakeholder management skills thriving in a very dynamic environment.

Your New Team & Department

You will be part of the QA Tech Transfer Team and report to the Head of the DS QP team. You will have 3 close colleagues in the QA tech transfer team and a large group of QA colleagues, who will be your everyday sparring partners. We are on-site most of the week and sit together.

You will collaborate with project teams with cross functional members in the organization.

Our environment is international and informal, emphasizing psychological safety through trust and empowerment, a high pace, and a vital life balance with plenty of fun.

Application

Has this sparked your interest? Then we urge you to please upload your CV and cover letter in English as soon as possible as we will be doing interviews on an ongoing basis. Should you have any questions, please feel free to reach out to Associate Director christina.schmidt@fujifilm.com.

FUJIFILM Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.

 Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.

Shape the future with us—your drive meets boundless opportunity here https://fujifilmbiotechnologies.fujifilm.com/

 FUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.

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